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GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Chronic Genotype 1 Hepatitis C Virus

NCT01356160 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2014-02-03

No results posted yet for this study

Summary

This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

GS-5885

tablet, 30 mg QD

DRUG

GS-9451

tablet, 200 mg QD

BIOLOGICAL

peginterferon alfa-2a

(solution for injection) 180 µg/week

DRUG

ribavirin tablet

ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)

DRUG

GS-9451 Placebo

Placebo to match GS-9451 QD

Sponsors & Collaborators

Principal Investigators

  • Bittoo Kanwar, MD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States
  • Australia
  • Puerto Rico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01356160 on ClinicalTrials.gov